Study Evaluating the Effects of PSI-697 on Platelets in Subjects Who Smoke
NCT03860506
ABOUT THIS STUDY
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- Any diagnosed bleeding disorder.
- Any major surgical procedure within 6 months before study day 1.
- Any history of major bleeding (eg, bleeding peptic ulcer) within 1 year before study
day 1.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Evaluating the Effects of PSI-697 on Platelets in Subjects Who Smoke | |||
Official Title ICMJE | A Double-Blind, Placebo-Controlled, Randomized, Single-Dose, 2-Period Crossover Study of the Pharmacodynamics of Orally Administered PSI-697 in Healthy Subjects Who Smoke | |||
Brief Summary | This is a single dose inpatient and outpatient study to test whether an effect on the ability of platelets to stick to white blood cells in subjects who smoke. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 30 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | July 1, 2008 | |||
Actual Primary Completion Date | July 1, 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: Inclusion Criteria:
Exclusion Criteria: Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT03860506 | |||
Other Study ID Numbers ICMJE | 3165A1-1108 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | February 2019 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |